The present invention relates generally to an elastomeric closure having a barrier film layer. In particular, the present invention relates to an elastomeric closure having a barrier film layered internally of the elastomeric closure.
Elastomeric closures are generally used as sealing devices for vials, medical vessels, instruments, syringes, etc. For a closure material of a medicament vessel, it is generally required that the material have heat resistance, compression strain resistance, be chemically inert, and have a low permeability to gases and water vapor. In this respect, elastomers, which have excellent sealing properties, are often used for closure materials for medicament vessels. However, conventional elastomers, while generally having low permeability, still suffer from the permeation and transmission of gases, such as water vapor and oxygen. The transmission of water vapor through elastomeric closures have become of greater concern in today's medical field due to the ever increasing sensitivity of drugs, such as lyophilized and modern biotech drugs and other moisture sensitive products stored in such medicament vessels over extended periods of time, such as several years. Lyophilized and biotech drugs are highly sensitive to even very low levels of water and therefore, a moisture barrier closure is required. Such exposure to water for lyophilized and biotech drugs can adversely effect the performance and stability of the drugs. The problems associated with water vapor transmission are further aggravated when lyophilized or biotech drugs are stored for extended periods of time during shelf life. The shelf life of such drugs itself may be limited due to the effects of water vapor transmission into the drug's container.
Accordingly, a need still exists for an elastomeric closure that can sufficiently seal a vessel or device and provide a barrier to the transmission of water vapor and/or oxygen and other fluids through the closure without introducing the barrier material as a secondary source of contamination for the vessel or its contents.